Preclinical Regulatory, Manager

Group Purpose

Facilitate patient access to Amgen products in Japan through executing the development and regulatory plans; providing strategic regulatory expertise; interfacing with agencies on regulators; aligning with key cross-functional partners; integrating into Amgen’s commercialization process, and continuously improving our processes and developing our talent.

Job Summary

• Execute local preclinical documentation (Investigators Brochure for J-CTN, Briefing Document for PMDA consultation, and CTD preparation for J-NDA) and RTQs from Japan Health Authorities with Global Translational Science and Preclinical Development and manage outside service providers

• Bring local preclinical expertise to Japan Project Teams and Global Product Strategic Teams in Amgen

Key Activities

• Ensure quality of contents and of Japanese translation of preclinical parts in CTD for J-NDA and IB for J-CTN

• Input Japan-specific requirements for preclinical development to global members as a local expert

• Prepare and respond to preclinical questions for CTD and IB from PMDA with global members

• Interact with Japanese healthcare providers (PMDA, academic organizations, and National Institute of Health Science) to obtain acceptability of preclinical data for J-NDA of innovative medicines

• Interact with Key Opinion Leaders and/or Principle Investigators to convey preclinical knowledge of candidates (more of a focus area in Japan than in the west)

Knowledge and Skills

• Knowledge of preclinical science (toxicology, pharmacology, and/or drug metabolism)

• Knowledge for documentation (preclinical writing) and the quality of IB and CTD

• Knowledge of Preclinical regulations/guidelines (including GLP and ICH) in Japan

• Preclinical (toxicology, pharmacology, and/or drug metabolism) experiences in research lab

• Working in matrix environments as One Team

• Communication skills

• Negotiation skills to Japan Health Authorities

• English conversation, read, and writing

• Computers: Microsoft Outlook/ Word/ Excel/Power Point

Education & Experience (Basic)

Master or Doctorate degree and 10 years of directly related experience

Over total 5 years experiences with preclinical pharmacology, toxicology and/or drug metabolism for supporting CTN and NDA submission in Japan

Over 5 years experiences in pharmaceutical industry

Education & Experience (Preferred)

Over  5 NDA submissions and approvals in Japan (more preferred biologic experience)